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Last Updated: November 18, 2019

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Details for New Drug Application (NDA): 021802

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NDA 021802 describes FOCALIN XR, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and six Paragraph IV challenges. Additional details are available on the FOCALIN XR profile page.

The generic ingredient in FOCALIN XR is dexmethylphenidate hydrochloride. There are six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dexmethylphenidate hydrochloride profile page.
Summary for 021802
Tradename:FOCALIN XR
Applicant:Novartis
Ingredient:dexmethylphenidate hydrochloride
Patents:2
Pharmacology for NDA: 021802
Medical Subject Heading (MeSH) Categories for 021802
Suppliers and Packaging for NDA: 021802
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NDA Novartis Pharmaceuticals Corporation 0078-0430 0078-0430-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0430-05)
FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802 NDA Novartis Pharmaceuticals Corporation 0078-0431 0078-0431-05 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0078-0431-05)
Paragraph IV (Patent) Challenges for 021802
Tradename Dosage Ingredient NDA Submissiondate
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2011-09-30
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2011-09-29
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2010-12-20
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2010-12-15
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2007-05-14
FOCALIN XR CAPSULE, EXTENDED RELEASE;ORAL dexmethylphenidate hydrochloride 021802 2007-03-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 26, 2005TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Patent:  Start TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 26, 2005TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Nov 1, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION

Expired US Patents for NDA 021802

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-004 Aug 1, 2006   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-003 May 26, 2005   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-005 Oct 23, 2009   Start Trial   Start Trial
Novartis FOCALIN XR dexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021802-008 Apr 21, 2011   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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